Oxbryta (voxelotor)
OrphanPRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- voxelotor
- Company
- Pfizer Europe MA EEIG
- Status
- Suspended
- Therapeutic area
- Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Mon 14 Feb 2022
- Designations
- Orphan, PRIME, Additional monitoring
- Application
- EMEA/H/C/004869
- ATC
- B06AX03
- Official record
- www.ema.europa.eu
Indication
Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.
Regulatory milestones
Tue 09 Dec 2025🇪🇺 Referral EC decision
Oxbryta: EC decision
Article 20 procedures; European Commission final decision · source
Thu 16 Oct 2025🇪🇺 Referral opinion
Oxbryta: CHMP opinion
Article 20 procedures; European Commission final decision · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.